1

Table of ContentsA.Main Page..........................................................................................................................................4

1.Research title..................................................................................................................................4

2.Name of researcher........................................................................................................................4

3.Research Supervisor........................................................................................................................4

4.Keywords........................................................................................................................................4

5.Duration of research (Months).......................................................................................................4

6.Budget.............................................................................................................................................4

B.STATEMENT AND VERIFICATION........................................................................................................5

7.Researcher’s statement..................................................................................................................5

8.Verification from the responsible supervisor and the chairman of Research Module....................5

C.RESEARCH DESCRIPTION....................................................................................................................6

9.Background.....................................................................................................................................6

10.Problem Identification and Research Question(s).........................................................................7

Research problem :........................................................................................................................7

Research questions :.......................................................................................................................7

Hypothesis :....................................................................................................................................7

11.General Objective, Specific Objective and Research Benefit.........................................................7

General Objective:..........................................................................................................................7

Specific Objective(s):......................................................................................................................7

Research Benefit(s):.......................................................................................................................8

12. Literature Review and Conceptual Frame....................................................................................9

Tuberculosis...................................................................................................................................9

Introduction...................................................................................................................................9

Stop TB strategy in Indonesia.........................................................................................................9

DOTS program................................................................................................................................9

2

Medication of TB..........................................................................................................................10

Isoniazida......................................................................................................................................10

How does Isoniazida works?.........................................................................................................10

Clinical Uses..................................................................................................................................11

Compliance of the patient............................................................................................................11

Age Group....................................................................................................................................12

Theoritical Framework.....................................................................................................................13

Conceptual Framework....................................................................................................................14

13. Methods.....................................................................................................................................15

1.Design........................................................................................................................................15

2.Time and Place..........................................................................................................................15

3.Research Material.....................................................................................................................15

4.Research Procedure..................................................................................................................15

5.Population.................................................................................................................................16

6.Sample.......................................................................................................................................16

7.Inclusion and Exclusion criteria.................................................................................................17

8.Variable:....................................................................................................................................18

9. Operational Definition..............................................................................................................18

10.Methods for Data Collection...................................................................................................19

11.Data Analysis...........................................................................................................................20

12. Time Frame.............................................................................................................................21

14. Research Ethics..........................................................................................................................23

15. References.................................................................................................................................24

APPENDICES.....................................................................................................................................26

Appendices 1: Information for the prospective subject.............................................................26

Appendices 2:Informed Consent.................................................................................................26

3

Appendices 3: Booklet.................................................................................................................27

Identity Page................................................................................................................................28

Data Page.....................................................................................................................................29

Appendices 4 : Patient Medical Record (Form A1)......................................................................30

4

A.Main Page

1.Research titleDifference of TB drug compliance between elderly patient and non-elderly patient in a DOTS

environment

2.Name of researcherName: Aldo Ferly NPM: 0906550575

3.Research SupervisorName: Prof.Dr.dr. Rianto Setiabudy SpFK

Department: Pharmacology

4.KeywordsTubercolosis Directly Observed Treatment

Environment

Drug Consumption Compliance

Geriatric Medicine

5.Duration of research (Months)The research will be conducted in a total period of 6(six) months

6.BudgetRp2.836.685,00

5

B.STATEMENT AND VERIFICATION

7.Researcher’s statementWe herewith confirm that:

a. This research proposal with title stated in the main page is an original research, not a plagiarism

b. We agree to conduct the research with title stated in the main page

Researcher(s)

Aldo Ferly

Signature(s) Date

8.Verification from the responsible supervisor and the chairman of Research Module

Signature of Supervisor

(Name : ................................)

Signature of Chairman of Research Module

(Name : DR. dr. Saptawati Badarsono, MS)

C.RESEARCH DESCRIPTION

9.Background

6

Tubercolosis is a bacterial infection caused by the bacterial called Myobacterium

Tubercolosis infection.

Indonesia is the third largest Tubercolosis-infected country in 2008, according to the

latest survey by WHO Regional Office for South East Asia, TB incidence is 228 per 100,000

population, TB prevalence is 244 per 100,000 population and mortality is 39 per 100,000

population

One of the main problem of eradicating TB is low drug compliance among TB patient,

drug compliance is important because if the medication period of 9 months is not finished

completely, TB will relapse and a new more violent strain of TB will appear which immune to

previous medication. American Journal of Respiratory Care and critical care medicine

recorded that up to 77% of TB case is in fact recurring TBi

In order to fight the compliance problem Ministry of Health of Indonesia with World Health

Organization made a program which is called WHO-Indonesia Joint Evaluation that

recommends the changing of the strategy in handling the problem of Tubercolosis in

Indonesia. Since the year of 1995, Indonesia impliments new program to fight the

tubercolosis bacteria which is called the DOTS(Directly Observed Treatment Shortcource

Chemotherapy) program. By previous research it is proven that DOTS program is effective in

increasing the compliance of the patient.ii

According to Gerakan Terpadu Penanggulangan Tuberkolosis, even thought that most

cases of TB happened between the age of 15 to 55 years old, which is the productive age

but from year to year, there are large increase of incidence rate moves into the older

generation with it’s peak between the age of 55 to 64. This high incidence rate poses serious

treat because it might increase the prevalence rate of elderly with TB. Considering the

condition of the elderly people, the effectiveness of TB therapy might be different from adult

patient.iii

7

10.Problem Identification and Research Question(s)

Research problem :The research problem that we are going to address here is the effectiveness of DOTS program

especially in elderly people that can be measured by drug compliance.

Research questions :According to the research problem and background information above, We can make the

following research questions:

1. Is there any difference of TB drug compliance between elderly patient and non-elderly

patient in a DOTS environment?

Hypothesis :There are difference of TB drug compliance between elderly patient and non-elderly patient in a

DOTS environment

11.General Objective, Specific Objective and Research Benefit

General Objective:1. To find out whether there are difference of TB drug compliance between elderly patient

and non-elderly patient in a DOTS environment

Specific Objective(s):1. To identify the age group of the patient, whether they belong to elderly patient or non-

elderly patient

2. Measure the number of medication that they consumed in a month and categorize

wheter they are compliant or not

3. Find out if there are any difference of compliance between the elderly and non-elderly

patient

Research Benefit(s):Benefit(s) for the researcher:

To pass the necessary requirement of the first stage of research module of Faculty of

Medicine University of Indonesia

8

To prepare our research practice that will be conducted from the second to the sixth

semester

To improve the researcher’s skills both in theory and application of making a good

research

To gain knowledge of TB and understanding the effect of age group to TB drug

consumption compliance

Benefit(s) for the Institution:

To fulfill Tri Darma Perguruan Tinggi with its vision of conducting education, research,

and dedicative service to the community

To realize the vision of Faculty of Medicine University of Indonesia 2010

Benefit(s) for the government:

Increase government care for the elderly

To Evaluate the effectiveness of the ongoing DOTS program

To be used to develop the enhanced DOTS program

Benefit(s) for the Society:

To educate the society of the effect of different age group in drug consumption

compliance

12. Literature Review and Conceptual Frame

Tuberculosis

IntroductionTuberculosis is an infectious disease which cause the highest mortality in the world. The

World Health Organization predicts that 2 billion people have latent TB, 3 million people die of

this disease annually.iv

Stop TB strategy in IndonesiaMinistry of Health in the book Kerangka Kerja Strategi Pengendalian TBC di Indonesia

tahun 2006-2010 made a strategic plan to control TB which consists of:

9

Expansion of TB control:Error: Reference source not found

1. Pursue quality DOTS expansion and enhancement

2. Address TB/HIV, MDR-TB and other challenges

3. Involve all care provider

4. Engage TB patients and affected communities

Supported by health system strengthening

1. Strengthened policy and ownership

2. Strengthened health system and TB control management

3. Research

For this research, we will focus more on the first step of Expansion of TB control which is to

pursue quality DOTS expansion and enhancement

DOTS programIn 1994, Indonesian government make a collaboration with the World Health

Organization(WHO), making a committee on evaluation of TBC which is called WHO-

Indonesian Joint Evaluation, this committee makes the recommendation of the need to make

substantive change in the strategy to eradicate TB from Indonesia which is called “DOTS

Strategy” from that moment DOTS strategy was born. v

DOTS itself is an acronym for Directly Observed Treatment Shortcourse which mean a

direct consumption of medication in the presence of Drug Consumption Observer (DCO)

The primary aims of this program are to have a high recovery rate of TB patient, to

prevent TB patient to stop the medication before fully cured and to prevent any side effect of the

medication and any resistance of the medication.

Before the first treatment commence, DOTS must be explained to the patient both the

mechanism and also the benefits. One DCO must be chosen and present in the polyclinic. DCO

must be a person who wants to help the patient until he or she fully recover(at least 6 months)

usually DCO is a family member which is trusted by the patient.

Medication of TB

10

The medication of TB is four drugs which are: Isoniazida, Rifampisin, Pirazinamida,

Streptomisin and Etambutol. These drugs are given in combination. These drugs are now

combined into one tablet which is called four in one.vi

In medication of TB the main problem is that many doctor does not follow the standard

protocol from the ministry of health and prescribe the 4 drugs separately, this will make the

patient confused and decrease the compliance of the patient.

In the following passage, we will discuss briefly about the type of TB medication used in this

study

Isoniazidavii

Isoniazid is the most active drug for the treatment of tuberculosis caused by susceptible

strains. The size of Isoniazida structure is small and can be easily solubled in water.

How does Isoniazida works?Inside the bacteria body, This drug inhibits most tubercle bacilli in a concentration of 0.2

mcg/mL or less and is bactericidal for actively growing tubercle bacilli. It is less effective against

atypical mycobacterial species. Isoniazid penetrates into macrophages and is active against

both extracellular and intracellular organisms

Clinical UsesThe usual dosage of isoniazid is 5 mg/kg/d; a typical adult dose is 300 mg given once

daily. Up to 10 mg/kg/d may be used for serious infections or if malabsorption is a problem. A

15 mg/kg dose, or 900 mg, may be used in a twice-weekly dosing regimen in combination with a

second antituberculous agent (eg, rifampin 600 mg). Pyridoxine, 25–50 mg/d, is recommended

for those with conditions predisposing to neuropathy, an adverse effect of isoniazid. Isoniazid is

usually given by mouth but can be given parenterally in the same dosage.

Isoniazid as a single agent is also indicated for treatment of latent tuberculosis. The

dosage is 300 mg/d (5 mg/kg/d) or 900 mg twice weekly for 9 months.

Compliance of the patientThe compliance of the patient is one of the main concern of TB medication. TB

medication must be taken for 6 to 8 months. The length of the medication usually makes the

patient bored and stopped in the middle of the medicationviii

11

Usually, after taking medication for 2 months, patient feel healthy and stop the

medication. Actually, the wellness feeling of the patient does not mean that TB germs are fully

eradicated. It is generally accepted that a TB medication can only stop after 6 to 8 months of

treatment.

The lack of compliance in taking medication is one of the largest problem in eradicating

TB. If the patient is not compliance, TB germs will be resistant to the medication and in turn will

be much more ferocious. If that condition happened, the medication will be much more

complicated, the drugs will be much more limited, the time of the medication will be much more

longer and also the medication will be much more costly. Moreover, the patient will be a source

of future spreading of the “improved” disease toward the society

This is a very serious problem. In the DOTS strategy, this problem is solved by using

“Increased surveilence”. Every TB patient have their own Drug Consumption Observer who

have the obligation to remind the patient to take their own medication. DCO is trained to ensure

that the patient really take the medication in the limited time constraint. DCO must ensure and

observe that the patient really take the medication.Error: Reference source not found

According to WHO, the definition of compliance is taking 85% of the medication. In this

study we use this definition to term compliance.ix

Age Group In this research we divide the age into several categories according to age cycle, life

cycle grouping which are: below 65 and above 65 these 2 categories represents. According to

the classification according to life cycle grouping, age above 65 is considered as elderly.

There are several factors which enables that the elderly age group has different drug

compliance with the non-elderly. The three factors are: memories, activity and other diseases

beside TB

Elderly memories are different with the adults memory, elderly people are more prone to

many memory-related disease such as Alzheimer disease that can decrease the memory. The

decrease of the memory might lead to low compliance because the subject does not remember

taking the medication

12

Activity means that elderly people has different set of activity with younger person. For

example, the elderly must spent time more in sleeping than the younger person. This might

affect the compliance of the medication in older people

Other disease beside TB means that older people usually have more than 1 disease so,

the medication will be much more complicated than younger people.

Theoritical Framework

13

Conceptual Framework

14

13. Methods

15

Compliance of

TB Medication

1.DesignThis research use cross sectional design to try to find out association between the age

group and the compliance of drug consumption in TB patient.

2.Time and PlaceThis research will take place in puskesmas cawang from November 1st 2009 to June 1st

2010

3.Research MaterialMaterials needed for this research are:

Isoniazida

Booklets to record everyday TB consumption

Form to record the medication that the patient returned in the end of the month

4.Research ProcedureThe procedure of this research is as following

1. In the 1st of March 2010, participants of this research will be given medication of TB

according to their usual TB medication, participants are asked to take the medication

normally and record any drug consumption on the booklets provided. The researcher

must tell the patient to bring the medication that he/she has not finished consumed after

a month but do not tell them that the medication will be counted

a. Rules concerning the consumption of medication are in line with DOTS program

guidelines including the presence of Drug Consumption Observer

2. In the end of the month, 31st of March 2010, participants are asked to return the

medication that they have not yet finished consume in the one month period. Some

medication are expected to be returned by each of the research participant.

3. The researcher count the medication returned by the patient and fill form A1(see

appendices) which objective is to record the name of the patient, their Drug

Consumption Observer and the medication returned.

4. Make sure the number returned are according to the booklets that records daily TB

consumption

5.Population

16

Target PopulationIn this research, the target population is pulmonary TB patient taking medication in DOTS environment

Accessible populationAccessible population for this research is the patient of pulmonary TB patient currently taking medication of TB in puskesmas cawang in the period of march-april 2009

6.SampleSample choosing method:

In this research, we choose the sample based in systematic sampling method.

simple illustration of systematic sampling method:

Suggest that in puskesmas Cawang we want to choose 20 patient out of 200 patients

using the method of systematic sampling, so, it is needed 20/200 or in other words 10 out of 100

patients, so, every 10 patient will be chosen by the researcher. In the beginning of the research

every subject was given number from 1 to 200. Every 10th patient will be chosen as sample. The

determinant of the first number should be done randomly for example by using pencil tip. If, for

example, the first number is 3 than patient number 3,13,23,33,43,53 … will be chosen as

research subject.

Sample Sizex

The number of the sample used in this study will follow the minimum sample size formula for

cross-sectional study. The formula used for this study is:

The definition of each symbols are:

n = sample size

P = proportion of the condition that we are going to find out

q = 1-P

d = different between proportion of the sample and population

17

= Value of normal curve according to which is the confidence level

In this section, we are going to determine each of the value above

P

From the literature, we found out that TB prevalence in Indonesia is 0.00224 therefore the value

of P is 0.00224

q

The value of q is 1-0.00224 which is 0.99776

d

We want that the relative accuracy of this study is 1% therefore, the value of d is 0.01

In this study, we want to minimize the type 1 error to 5% so, the value of according to

normal curve value is 1.96

So, from the explanation above, we will calculate the sample size needed:

= 85

However, we must add 10% of the population to safeguard against dropout sample:

85+(10% x 85) = 85+8.5 = 94

The final sample size needed is 94 people

7.Inclusion and Exclusion criteria

Inclusion criteria:1. Patient of pulmonary TB in the period of January-October 2010

2. Patient participate in DOTS program in eradicating TB done by the ministry of health

3. Patient has taken TB medication for 2 to 5 months

18

4. Both genders are eligible

Exclusion criteria:1. Patient have conditions and/or disease that could disturb interpretation of the result

2. Patient does not have any close relative/person that act as Drug Consumption Observer

3. Patient refuse to participate

Drop out criteria:1. Patients failed to record the daily drug taking activity in the book provided by the

researcher

2. Patients failed to return the drug in the end of the month

3. Researcher Lose contact with the patient

4. Patient lose contact with their DCO during the medication period

8.Variable:In this study, the independent variable is the age of the subject with the possible value

as 2 categorial data which are: below the age of 65 or above the age of 65

The dependent variable is the compliance of the subject to the medication give

according to the DOTS guideline, the compliance of the medication is categorized into

compliant, if the patient consumed more than 85% of the medication or non-compliant if the

patient consumed less than 85% of the medication.

9. Operational DefinitionTo avoid misinterpretation and misguidance, important terms in this research are defined as

follow:

The term compliance in this procedure refers to number of medication. The patient is

said to comply if he/she takes 85% of the medication

The term non-compliance in this procedure if a patient failed to take 85% of the

medication

Tuberculosis in this program refers to the bacteria Mycobacterium tubercolosis that

affect lung

DOTS program is a program in eradicating TB outlined in Indonesian-WHO joint

evaluation(1994)

Age is a period from the delivery shown by the date of birth in the identity card until now

19

DCO(Drug Consumption Observer) is a person assigned to observe the drug

consumption of the patient

10.Methods for Data CollectionFirst, the patient must understand the procedure for the experiment, the aim and

purpose of the experiment and sign the informed consent paper that will have been prepared by

the research team in 1st of March 2010.

In the 1st of March 2010, patient and his/her DCO will be given the medication needed

monthly medication. The amount of the drug is according to their usual monthly TB medication +

10% buffer size. For example: if the person usual monthly medication is 60 tablets, then the

medication that is given is 60+(10% x 60) = 66 tablets.

The patient and their DCO are asked to fill the booklet prepared by the researcher team

throughout the 1 month medication period.

In 1st of April 2010, research team will collect the booklets and the medication that the

subject has not finished during the 1 month period. The data collection will be in the puskesmas

Cawang. After the samples are collected, the following steps must be taken by the researcher:

Calculate the medication returned by the test subject. The number returned by

the patient will determine the drug compliance of the patient

Analyze the booklet to determine if the number of medications returned are

caused by compliance or other factor (misplaced drug etc.)

11.Data AnalysisAfter the results have been collected, the researcher will use the data to determine these

four outcomes:

Subject with age higher than 65 with high drug compliance

Subject with age higher than 65 with low drug compliance

Subject with age lower than 65 with high drug compliance

Subject with age lower than 65 with low drug compliance

20

Then, We fill the group to this table

Subject with age

lower than 65

Subject with age

higher than 65

Total

Subject with low drug

compliance

a B a+b

Subject with high drug

compliance

c D c+d

Total a+c b+d a+b+c+d

Then, we move to the next part which is Inferential Statistics

Inferential Statistics

The first step that we should do in doing statistical analysis is determine the null hypothesis

Null hypothesis

There are no correlation between age group on drug consumption compliance of a pulmonary

tubercolosis patient in a directly observed treatment environment

Alternative hypothesis

There are correlation between age group on drug consumption compliance of a pulmonary

tubercolosis patient in a directly observed treatment environment

Stastical Analysis

21

The data analysis will be done with SPSS 16.0 software which is available in the Faculty

of Medicine University of Indonesia computer lab.

Because the data is between two categorical data which are age group and consumption

compliance, we will use the chi-square test to determine if the result of this study is statistically

significant or not. In doing the chi-square test, we must remember that there are 2 conditions

that must be fulfilled so the test can be done:xi

1. No cells in the crosstable are empty

2. No cells have expected count less than 5

If the condition cannot be fulfilled then we should use another test called fisher test. The

significant result of both the chi-square test or the fisher test then is used to found out is the

result. if the result <0.05 then the result is considered statistically significant and we reject the

null hypothesis.

12. Time FrameNov

09

Dec

09

Jan 10 Feb 10 Mar 10 Apr 10 May 10 Jun 10

Make research

proposal

X

Proposal

submission

X

Proposal

evaluation

X

Booklet

printing

X X

Preparation of

Medication

X

22

Data collection X

Data analysis

and

interpretation

X X

Report writting X

14. Research Ethics.

This study uses human as it’s subject, but the discomfortnes of the subject of this study will be

minimal since the medication that the patient use are the same as what they received every

other month.

Factor that will possibly cause discomfort in the patient is the obligation for the patient to come

to the puskesmas the day the research began in the 1st of March 2010 to receive the drug

consumption booklet and 1st of April 2010 to collect the booklet and the medication that has not

yet been consumed. Our effort to minimize the discomfort is to increase the number of our

researcher collecting the data and giving the booklet so, the waiting time will be minimalized

23

To compensate with the discomfortness that the patient may experience in this research,

researcher will pay for the drug in the month of the research.

This research will upheld ethical value highly especially the value of autonomy, beneficence,

non-malefience and justice.

In this study, we believe that patient autonomy must be held with highest appreciation in order

to achieve that we must make sure that the patient really understand the research and the

subject will be given informed consent, which gives their approval about their participation in this

study. Patient who refuse to participate in the study must be excluded from the study

The principle of beneficence and non-maleficence is shown by ensuring that every medication

given to the patient valid and does not expired

The principle of justice is shown by treating every patient with the same manner regardless of

the background.

This proposal will be reviewed by the ethical commission of the FKUI in order to have ethical

clearance to do the research.

15. References1Badan Pusat Statistik. TB in Indonesia [pamphlet]. Jakarta:Penerbit Departemen Kesehatan;

20082 Moulding, TS. Medication Monitors to Treat Tuberculosis. American Journal of Respiratory and

Critical Care Medicine 1999;159:989-991

3 Burman WJ. Effectiveness of Time and Cost of DOTS program against SAT in Denver.

DenverMed 19944 Supari SF. Kerangka Kerja Penanggulangan TB 2006 – 2010. Jakarta: Departemen

Kesehatan;2006

24

5 Reddy TB, Riley R, Wymore F, Montgomery P, Decaprio D, Engels R, Gellesch M, Hubble J,

Jen D, Jin H, Koehrsen M, Larson L, Mao M, Nitzberg M, Sisk P, Stolte C, Weiner B, White J,

Zachariah ZK, Sherlock G, Galagan JE, Ball CA, Schoolnik GK. TB database: an integrated

platform for tuberculosis research. Nucleic Acids Res doi: 10.1093/nar/gkn6526 Permatasari A. Pemberantasan Penyakit TB Paru dan Strategi DOTS.e-USU repository 2005

7 Obat Anti Tuberkulosis (OAT) Program TBC. [Online]. 2009 [cited 2009 Nov 17]; Available

from: URL: http://www.tbindonesia.or.id/tbnew/obat/article/61/0003/48 Katzung BG., Basic and Clinical Pharmacology. 10th ed. San Fransisco(CA):Mcgraw Hill;2006.

9Senewe FP. Faktor-Faktor yang Mempengaruhi Kepatuhan Berobat Penderita Tuberulosis

Paru di Puskesmas Depok.BulPenelKesehatan 2002; 30:31-38

10Tuberculosis. [Online]. 2009[cited 2009 Nov 18]; Available from: URL:

http://www.who.int/topics11Age Categories, Life Cycle Groupings. [Online]. 2008 [cited 2009 Nov 18]; Available from:

URL: http://www.statcan.gc.ca/concepts/definitions/age2-eng.htm12Sastroasmoro S. Ismael S., Dasar-dasar Metodologi Penelitian Klinis. 3rd ed. Jakarta:Sagung

Seto;200713Muhlisi LA. Pengaruh Gender Terhadap Kepatuhan Minum Obat Penderita Tuberkulosis

Dengan Menggunakan Program DOTS di Kabupaten Purworejo.UGM repository 2004

16.Detail of BudgetType of Cost Subtype Information Amount

Transportation Rp 150.000,00

Photocopy

Booklet 95x10x100 Rp 95.000,00

Consent 95x100 Rp 9500,00

Souvenir

Patient 95x4000 Rp 380.000,00

Drug Cost

25

Puskesmas 29x67.045 Rp1.944.305,00

Sub total Rp2.578.805,00

Unpredicted cost 10% from sub total Rp 257.880,5

Rp2.836.685,00

i Moulding, TS. Medication Monitors to Treat Tuberculosis. American Journal of Respiratory and Critical Care Medicine 1999;159:989-991

ii Burman WJ. Effectiveness of Time and Cost of DOTS program against SAT in Denver. DenverMed 1994iii Supari SF. Kerangka Kerja Penanggulangan TB 2006 – 2010. Jakarta: Departemen Kesehatan;2006iv Reddy TB, Riley R, Wymore F, Montgomery P, Decaprio D, Engels R, Gellesch M, Hubble J, Jen D, Jin H, Koehrsen M, Larson L, Mao M, Nitzberg M, Sisk P, Stolte C, Weiner B, White J, Zachariah ZK, Sherlock G, Galagan JE, Ball CA, Schoolnik GK. TB database: an integrated platform for tuberculosis research. Nucleic Acids Res doi: 10.1093/nar/gkn652v Permatasari A. Pemberantasan Penyakit TB Paru dan Strategi DOTS.e-USU repository 2005

vi Obat Anti Tuberkulosis (OAT) Program TBC. [Online]. 2009 [cited 2009 Nov 17]; Available from: URL: http://www.tbindonesia.or.id/tbnew/obat/article/61/0003/4vii Katzung BG., Basic and Clinical Pharmacology. 10th ed. San Fransisco(CA):Mcgraw Hill;2006.

viii Senewe FP. Faktor-Faktor yang Mempengaruhi Kepatuhan Berobat Penderita Tuberulosis Paru di Puskesmas Depok.BulPenelKesehatan 2002; 30:31-38

ix Tuberculosis. [Online]. 2009[cited 2009 Nov 18]; Available from: URL: http://www.who.int/topics

x Sastroasmoro S. Ismael S., Dasar-dasar Metodologi Penelitian Klinis. 3rd ed. Jakarta:Sagung Seto;2007xi Muhlisi LA. Pengaruh Gender Terhadap Kepatuhan Minum Obat Penderita Tuberkulosis Dengan Menggunakan Program DOTS di Kabupaten Purworejo.UGM repository 2004

26

APPENDICES

Appendices 1: Information for the prospective subjectThe recovery rate of TB in Indonesia is very low, one of the reason why this happens is because

of the low drug compliance of TB patient. Compliance in consuming medication especially in TB cases is

very important because TB will relapse if the patient does not finish the medication. In this study,

researche try to find out if there are any correlation between age and drug medication compliance of

TB patient.

This research is very important as previously in the DOTS program, the methods to handle

patient are same regardless of age. If there is difference of compliance between the age, ministry of

health should make new guideline to differentiate TB patient with higher age and also lower age

All patient data will be confidential and only be used for research purpose, If there is anything

that you do not understand please kindly ask the researcher.

Appendices 2:Informed ConsentInformed Concent

I have read and understand the experiment and agree to help the researcher in his research about Correlation of Age Group on Drug Consumption Compliance of a Pulmonary TB patient in a Directly Observed Treatment Environment.

By signing this form, I agree to participate in this study.

Jakarta, March 2010

Signature

(Full Name: ........................................................)

27

Appendices 3: BookletTitle Page

TB Medication Booklet

For

Correlation of Age Group on Drug Consumption Compliance of a Pulmonary Tubercolosis Patient in a Directly Observed Treatment Environment

Research Purpose

28

Identity PagePatient

Name : ………………………………………..

Age : ………………………………………..

Weight : ………………………………………..

Address : ………………………………………..

Contact Number : ……………………………………….

DCO

Name : ……………………………………….

Age : ……………………………………….

Address : ……………………………………….

Contact Number : ………………………………………

Relation to patient : ………………………………………

29

Data PageDate/Time : …………………/…………………..

Type of Medication : ………………………………………

Quantity : ………………………………………

DCO Sign

Date/Time : …………………/…………………..

Type of Medication : ………………………………………

Quantity : ………………………………………

DCO Sign

Appendices 4 : Patient Medical Record (Form A1)Patient

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Name : ………………………………………..

Age : ………………………………………..

Weight : ………………………………………..

Address : ………………………………………..

Contact Number : ……………………………………….

DCO

Name : ……………………………………….

Age : ……………………………………….

Address : ……………………………………….

Contact Number : ………………………………………

Relation to patient : ………………………………………

Drug

Drug given in the beginning of a month : …………………………..

Drug expected to be taken in a month : …………………………..

Drug returned in the end of the month : …………………………..

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